BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAD

    MDR report key: 2161816 · Received July 8, 2011

    Report

    Report Number
    2916596-2011-00285
    Event Type
    Injury
    Date Received
    July 8, 2011
    Date of Event
    May 4, 2011
    Report Date
    June 6, 2011
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE WAS RETURNED TO THE MFR FOR EVAL AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE ON (B)(6) 2010. IT WAS REPORTED BY THE VAD COORDINATOR THAT FOR A FEW WEEKS THE PT HAD BEEN EXPERIENCING "LOW VOLTAGE ADVISORY" ALARMS WHILE PLUGGED INTO THE POWER MODULE. THE SYS CONTROLLER AND POWER MODULE CABLE WERE EXCHANGED OUT. ON (B)(6) 2011, THE PT WAS SHOWERING WHILE CONNECTED TO THE POWER MODULE. AT SOME POINT DURING THE SHOWER, HE EXPERIENCED A " RED HEART" ALARM WHEN HE BENT OVER WHILE SITTING IN THE SHOWER CHAIR. HE GOT OUT OF THE SHOWER AND FELT A "WHOOSH" IN THE AREA OF HIS HEART AND ALSO FELT LIGHT HEADED. THE PT SWITCHED FROM THE POWER MODULE CONNECTION TO THE BATTERIES. THE ALARM DID NOT STOP UNTIL AFTER HE PLUGGED HIMSELF INTO THE BATTERIES. HE WAS ADMITTED INTO THE HOSP WHERE SEVERAL INCIDENTS OF "LOW VOLTAGE ADVISORY", FOLLOWED BY "LOW VOLTAGE HAZARD", "LOW SPEED OPERATION", "LOW FLOW", AND "PUMP OFF" ALARMS, WHILE PLUGGED INTO HIS POWER MODULE. THE PT BEGAN IS EXPLANT/RECOVERY WORK-UP AND THE PREVIOUS ALARMS WERE NEVER ABLE TO BE REPRODUCED ON THE POWER MODULE WHILE IN THE HOSP. THE MED STAFF THOUGHT THE PT MIGHT BE EXPERIENCING THE BEGINNING STAGES OF A PERCUTANEOUS LEAD FRACTURE. THE PT WAS EXPLANTED FOR RECOVERY ON (B)(6) 2011 AND STILL DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAD LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 103695 88425

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention